Status:
TERMINATED
Medical Therapies for Chronic Post-Traumatic Headaches
Lead Sponsor:
Madigan Army Medical Center
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Headache
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
Detailed Description
A total of 240 patients meeting International Classification of Headache Disorders (ICHD) diagnostic criteria for chronic post-traumatic headaches will be enrolled. Subjects will be recruited from the...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient meets ICHD criteria for chronic post-traumatic headaches (see below).
- Patient is 18-50 years old.
- Patient has experienced 6 or more days of headache per month for each of the last 2 months.
- Patient has full capacity to provide informed consent.
- Patient will be available for all study-related visits over the next 4 months.
- Patient must be eligible to receive care at Madigan Army Medical Center
- International Classification of Headache Disorders (version 2) diagnostic criteria for chronic post-traumatic headaches attributed to mild head injury:
- Headaches beginning within 1 week of mild traumatic head injury.
- Headaches persisting \> 3 months after head trauma.
- Head trauma with all of the following:
- no loss of consciousness or loss of consciousness \< 30 minutes
- Glasgow Coma Score (GCS) 13-15
- symptoms or signs diagnostic of concussion
- Exclusion criteria:
- Patient has another headache disorder not attributable to head trauma which accounts for at least half of the patient's headache episodes.
- Patient is currently taking propranolol, amitriptyline, or topiramate for any reason.
- Patient previously tried propranolol, amitriptyline, or topiramate for headache treatment.
- Patient started a new treatment for headache prevention within the last 6 weeks. Prophylactic treatments initiated prior to 6 weeks ago are allowed as long as the dose or regimen is stable. Medications for aborting acute headaches are also allowed.
- Patient previously tried more than two medications for headache prevention.
- Patient is using narcotic analgesics on average more than 10 days a month.
- Patient has a medical condition or is taking a medication that is considered a contraindication for propranolol, topiramate, or amitriptyline. Medical conditions include liver disease, renal impairment, cardiac dysrhythmias, untreated thyroid disease, orthostatic hypotension, asthma requiring treatment with inhalers, glaucoma, kidney stones, insulin-requiring diabetes, or pregnancy.
- Patient has known hepatic, renal, or cardiac disorders.
- Patient drinks on average more than two servings of alcohol (2 oz hard liquor, 5 oz wine, 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
- Patient has abnormalities on baseline EKG.
- Patient has major depression defined as a score \>15 on the Patient Health Questionnaire-9.
- Patient is pregnant, planning to become pregnant in the next year, or is a female of reproductive potential who is not using a reliable form of birth control.
- Patient has cognitive impairment defined as mini-mental status exam score \<27.
- SBP \< 90, HR \< 50, or HR \> 100.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00862095
Start Date
June 1 2008
End Date
April 1 2013
Last Update
April 23 2013
Active Locations (1)
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1
Madigan Army Medical Center
Tacoma, Washington, United States, 98431